MD4291C1 - Medicinal preparation for the treatment of otitis - Google Patents
Medicinal preparation for the treatment of otitis Download PDFInfo
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- MD4291C1 MD4291C1 MDA20130100A MD20130100A MD4291C1 MD 4291 C1 MD4291 C1 MD 4291C1 MD A20130100 A MDA20130100 A MD A20130100A MD 20130100 A MD20130100 A MD 20130100A MD 4291 C1 MD4291 C1 MD 4291C1
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- otitis
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- 238000002360 preparation method Methods 0.000 title claims abstract description 25
- 208000005141 Otitis Diseases 0.000 title claims abstract description 8
- 208000019258 ear infection Diseases 0.000 title claims abstract description 8
- 229960003957 dexamethasone Drugs 0.000 claims description 7
- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 claims description 7
- JCCNYMKQOSZNPW-UHFFFAOYSA-N loratadine Chemical compound C1CN(C(=O)OCC)CCC1=C1C2=NC=CC=C2CCC2=CC(Cl)=CC=C21 JCCNYMKQOSZNPW-UHFFFAOYSA-N 0.000 claims description 7
- 229960003088 loratadine Drugs 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 235000010676 Ocimum basilicum Nutrition 0.000 claims description 4
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 3
- 229960001229 ciprofloxacin hydrochloride Drugs 0.000 claims description 3
- DIOIOSKKIYDRIQ-UHFFFAOYSA-N ciprofloxacin hydrochloride Chemical compound Cl.C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 DIOIOSKKIYDRIQ-UHFFFAOYSA-N 0.000 claims description 3
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 3
- 229940068918 polyethylene glycol 400 Drugs 0.000 claims description 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 3
- 229940068977 polysorbate 20 Drugs 0.000 claims description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims description 2
- 240000007926 Ocimum gratissimum Species 0.000 claims description 2
- 239000007853 buffer solution Substances 0.000 claims description 2
- 239000012153 distilled water Substances 0.000 claims description 2
- 239000000341 volatile oil Substances 0.000 claims description 2
- 239000003814 drug Substances 0.000 abstract description 5
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 14
- 229940018006 basil oil Drugs 0.000 description 8
- 239000010619 basil oil Substances 0.000 description 8
- 239000000839 emulsion Substances 0.000 description 8
- 229960003405 ciprofloxacin Drugs 0.000 description 7
- 230000003110 anti-inflammatory effect Effects 0.000 description 6
- 239000000203 mixture Substances 0.000 description 5
- 230000001172 regenerating effect Effects 0.000 description 5
- 241001465754 Metazoa Species 0.000 description 4
- 239000006196 drop Substances 0.000 description 4
- 239000003221 ear drop Substances 0.000 description 4
- 229940047652 ear drops Drugs 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 210000003454 tympanic membrane Anatomy 0.000 description 4
- 230000009471 action Effects 0.000 description 3
- 238000010171 animal model Methods 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000002322 anti-exudative effect Effects 0.000 description 3
- 230000002421 anti-septic effect Effects 0.000 description 3
- 238000011161 development Methods 0.000 description 3
- 210000000613 ear canal Anatomy 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 238000002578 otoscopy Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 238000001228 spectrum Methods 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 206010020565 Hyperaemia Diseases 0.000 description 2
- 241000699670 Mus sp. Species 0.000 description 2
- 241001529734 Ocimum Species 0.000 description 2
- GLUUGHFHXGJENI-UHFFFAOYSA-N Piperazine Chemical compound C1CNCCN1 GLUUGHFHXGJENI-UHFFFAOYSA-N 0.000 description 2
- 230000003444 anaesthetic effect Effects 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 230000001139 anti-pruritic effect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 210000000883 ear external Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 229940124307 fluoroquinolone Drugs 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 206010033072 otitis externa Diseases 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 230000002195 synergetic effect Effects 0.000 description 2
- 230000000699 topical effect Effects 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 108010054814 DNA Gyrase Proteins 0.000 description 1
- 230000004543 DNA replication Effects 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- KRHYYFGTRYWZRS-UHFFFAOYSA-M Fluoride anion Chemical compound [F-] KRHYYFGTRYWZRS-UHFFFAOYSA-M 0.000 description 1
- 102000003834 Histamine H1 Receptors Human genes 0.000 description 1
- 108090000110 Histamine H1 Receptors Proteins 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 206010030113 Oedema Diseases 0.000 description 1
- 206010033078 Otitis media Diseases 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000003266 anti-allergic effect Effects 0.000 description 1
- 239000003908 antipruritic agent Substances 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000000975 bioactive effect Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 230000008499 blood brain barrier function Effects 0.000 description 1
- 210000001218 blood-brain barrier Anatomy 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 230000001914 calming effect Effects 0.000 description 1
- 230000004856 capillary permeability Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 208000024035 chronic otitis media Diseases 0.000 description 1
- 239000007979 citrate buffer Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000032625 disorder of ear Diseases 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000003862 glucocorticoid Substances 0.000 description 1
- 210000003128 head Anatomy 0.000 description 1
- 230000000742 histaminergic effect Effects 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 208000022760 infectious otitis media Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 208000030500 lower respiratory tract disease Diseases 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 229940126601 medicinal product Drugs 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 239000002395 mineralocorticoid Substances 0.000 description 1
- 239000002674 ointment Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 230000000079 pharmacotherapeutic effect Effects 0.000 description 1
- 150000003053 piperidines Chemical class 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 229910052573 porcelain Inorganic materials 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 210000002460 smooth muscle Anatomy 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 208000011479 upper respiratory tract disease Diseases 0.000 description 1
- 230000003639 vasoconstrictive effect Effects 0.000 description 1
- 239000005526 vasoconstrictor agent Substances 0.000 description 1
Landscapes
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
Invenţia se referă la medicină, în special la otorinolaringologie, şi anume la un preparat medicamentos pentru tratamentul otitelor. The invention relates to medicine, especially to otorhinolaryngology, namely to a medicinal preparation for the treatment of otitis.
Este cunoscută utilizarea preparatului medicamentos combinat Otinum sub formă de soluţie 10 ml, în calitate de medicament cu aplicare topică în tratamentul afecţiunilor urechii [1]. It is known to use the combined medicinal preparation Otinum in the form of a 10 ml solution, as a medicine with topical application in the treatment of ear diseases [1].
Dezavantajul preparatului menţionat constă în faptul că nu posedă efect regenerativ şi nu poate fi utilizat la otitele medii cu perforarea timpanului. The disadvantage of the mentioned preparation is that it does not have a regenerative effect and cannot be used for otitis media with perforation of the tympanic membrane.
Preparatele medicamentoase combinate presupun asocierea într-un singur preparat a doi sau mai mulţi agenţi cu acţiune terapeutică diferită asupra mai multor mecanisme ce intervin la declanşarea stării patologice. Medicamentele combinate manifestă sporirea efectului terapeutic prin acţiune sinergică, reducerea efectelor secundare la utilizarea unor doze mai mici de substanţe active cu reacţii adverse diferite, creşterea tolerabilităţii medicaţiei şi complianţa tratamentului. Combined medicinal preparations involve the association in a single preparation of two or more agents with different therapeutic action on several mechanisms involved in triggering the pathological condition. The combined drugs show the increase of the therapeutic effect through synergistic action, the reduction of side effects when using lower doses of active substances with different side effects, the increase of the tolerability of the medication and the compliance of the treatment.
Problema pe care o rezolvă invenţia solicitată constă în extinderea gamei de preparate medicamentoase sub formă de picături auriculare pentru tratamentul otitelor externe, otitelor medii acute şi otitelor medii cronice atât la cele fără perforaţia membranei timpanice, cât şi la cele perforative. The problem that the requested invention solves consists in expanding the range of medicinal preparations in the form of ear drops for the treatment of otitis externa, acute otitis media and chronic otitis media both in those without perforation of the tympanic membrane and in those with perforation.
Conform invenţiei, preparatul medicamentos revendicat conţine pentru 50 ml: According to the invention, the claimed medicinal preparation contains for 50 ml:
ciprofloxacină clorhidrat, g 0,148…0,152 ulei volatil de busuioc, g 0,198…0,202 loratadin, g 0,009…0,015 dexametazon, g 0,009…0,015 polisorbat 20, g 1,990…2,010 polietilenglicol 400, g 4,990…5,010 nipagin, g 0,019…0,020 soluţie tampon de citrat cu pH 7,8, g 0,010…0,020 apă distilată restul. ciprofloxacin hydrochloride, g 0.148...0.152 volatile oil of basil, g 0.198...0.202 loratadine, g 0.009...0.015 dexamethasone, g 0.009...0.015 polysorbate 20, g 1.990...2.010 polyethylene glycol 400, g 4.990...5.010 nipagin, g 0.019 ...0.020 buffer solution of citrate with pH 7.8, g 0.010...0.020 distilled water the rest.
Rezultatul constă în obţinerea unui preparat medicamentos combinat mai efectiv, rezultativ şi mai ieftin. The result consists in obtaining a more effective, effective and cheaper combined medicinal preparation.
Avantajul constă în aceea că preparatul propus datorită combinaţiei ingredientelor active posedă acţiune sinergică manifestată prin efectele regenerativ mai evidenţiat, precum şi antimicrobian, antiinflamator şi antiexsudativ, fapt ce contribuie la majorarea eficacităţii tratamentului otitelor nesupurative şi supurative. The advantage lies in the fact that the proposed preparation, thanks to the combination of active ingredients, has a synergistic action manifested by more pronounced regenerative effects, as well as antimicrobial, anti-inflammatory and anti-exudative, which contributes to increasing the effectiveness of the treatment of non-suppurative and suppurative otitis.
Ciprofloxacina reprezintă un remediu antibacterian din grupa fluorchinolonilor cu spectru larg de acţiune, activ faţă de un număr impunător de germeni patogeni. Mecanismul de acţiune constă în blocarea ADN-girazei microorganismelor sensibile şi a replicării ADN-ului. Fluorul este responsabil de lărgirea spectrului antibacterian pentru bacteriile gram-negative şi extinderea spectrului la bacteriile gram-pozitive. Ciclul piperazinic face preparatul activ contra pseudomonadelor. Ciprofloxacin is an antibacterial remedy from the group of fluoroquinolones with a broad spectrum of action, active against an impressive number of pathogenic germs. The mechanism of action consists in blocking DNA gyrase of sensitive microorganisms and DNA replication. Fluoride is responsible for broadening the antibacterial spectrum for gram-negative bacteria and extending the spectrum for gram-positive bacteria. The piperazine cycle makes the preparation active against pseudomonads.
Busuiocul (Ocimum basilicum) este o plantă cu mai multe efecte terapeutice. Posedă actiune antimicrobiană, antiinflamatorie, regenerativă, calmantă, uşor anestezică etc. Este pe larg utilizat inclusiv în tratamentul afecţiunilor tractului respirator superior şi inferior. Basil (Ocimum basilicum) is a plant with several therapeutic effects. It has antimicrobial, anti-inflammatory, regenerative, calming, slightly anesthetic action, etc. It is widely used including in the treatment of upper and lower respiratory tract diseases.
Loratadinul este un antiseptic cu acţiune periferică de lungă durată, derivat al piperidinei care blocheaza H1-receptorii histaminergici periferici. Nu depăşeste bariera hematoencefalică, are acţiune antialergică, antiexsudativă şi antipruriginoasă. Totodată scade permeabilitatea capilarelor, inlatură spasmul musculaturii netede, previne edemele ţesuturilor. Loratadine is an antiseptic with long-term peripheral action, a derivative of piperidine that blocks peripheral histaminergic H1-receptors. It does not cross the blood-brain barrier, has anti-allergic, anti-exudative and anti-pruritic action. At the same time, it decreases capillary permeability, removes smooth muscle spasm, prevents tissue edema.
Dexametazonul este un antiinflamator steroidian, glucocorticosteroid puternic lipsit de proprietăţi mineralocorticoide (nu reţine sodiul în organism). În aplicaţia topică posedă actiune antiinflamatoare, antipruriginoasă şi vasoconstrictoare. Dexamethasone is a steroid anti-inflammatory, strong glucocorticosteroid without mineralocorticoid properties (does not retain sodium in the body). In topical application, it has anti-inflammatory, antipruritic and vasoconstrictive action.
Forma farmaceutică reprezintă o emulsie uleioasă de tip ulei/apă pentru uz extern cu continut de ciprofloxacină clorhidrat, loratadin, dexametazon şi ulei volatil de busuioc. Preparatul medicamentos policomponent posedă un spectru de acţiune multidirecţionat şi asigură un efect terapeutic complex. Preparatul este caracterizat prin componenţa cantitativă şi calitativă valoroasă, conţinutul unor principii bioactive, lipsa elementelor nocive, simplitatea proceselor tehnologice. The pharmaceutical form is an oily emulsion of oil/water type for external use containing ciprofloxacin hydrochloride, loratadine, dexamethasone and volatile basil oil. The polycomponent medicinal preparation has a multidirectional spectrum of action and ensures a complex therapeutic effect. The preparation is characterized by its valuable quantitative and qualitative composition, the content of bioactive principles, the absence of harmful elements, the simplicity of the technological processes.
Etapele de elaborare a preparatului medicamentos The stages of the development of the medicinal preparation
1. Studiul compatibilităţii ciprofloxacinei şi uleiului de busuioc în aceeaşi formă farmaceutică. 1. Compatibility study of ciprofloxacin and basil oil in the same pharmaceutical form.
2. Elaborarea compoziţiei şi a tehnologiei de preparare a picăturilor auriculare. 2. Elaboration of the composition and preparation technology of ear drops.
2.1. Preformularea şi elaborarea tehnologiei de preparare optime a picăturilor auriculare cu conţinut de ciprofloxacină şi ulei volatil de busuioc. 2.1. Preformulation and development of the optimal preparation technology of auricular drops containing ciprofloxacin and volatile basil oil.
3. Elaborarea metodelor de analiză a picăturilor auriculare cu conţinut de ciprofloxacină şi ulei de busuioc. 3. Development of methods for analyzing ear drops containing ciprofloxacin and basil oil.
4. Standardizarea formei farmaceutice. 4. Standardization of the pharmaceutical form.
Procesul tehnologic de preparare a unguentului The technological process of preparing the ointment
Pregătirea emulsiei primare. Într-o cească de porţelan se introduce polisorbat 20, la care se adaugă cu picatura ulei de busuioc, se amestecă bine până la emulsionarea uleiului. Preparation of primary emulsion. Polysorbate 20 is introduced into a porcelain cup, to which basil oil is added drop by drop, mix well until the oil emulsifies.
Pregătirea substanţelor medicamentoase. Se cântaresc la balanţa analitică cantităţile necesare de substanţe medicamentoase. Preparation of medicinal substances. The necessary quantities of medicinal substances are weighed on the analytical balance.
Încorporarea substanţelor medicamentoase în emulsia primară. La emulsia primară se adaugă în porţiuni apă purificată (circa 1⁄2 din volumul ei) şi excipienţii. Loratadinul şi dexametazonul se dizolvă în polietilenglicol 400 şi se amestecă cu nipaginul în prealabil dizolvat într-o cantitate minimă de apă purificată din restul volumului; apoi se adaugă ciprofloxacina dizolvată în cantitatea minimă de apă din restul volumului. Se amestecă bine şi se omogenizează emulsia. Se măsoară pH-ul emulsiei şi dacă este cazul se ajustează cu ajutorul soluţiei tampon de citrat cu pH=7,8 (1 ml) până la pH-ul optimal 4,5…5,0. Emulsia obţinută este transferată într-un pahar gradat de 50 ml şi se completează până la cota necesară cu restul solventului. Emulsia obţinută are un aspect omogen, este lipsită de particule în suspensie, are un miros plăcut de ulei volatil de busuioc. Incorporation of medicinal substances into the primary emulsion. Purified water (about 1⁄2 of its volume) and excipients are added to the primary emulsion in portions. Loratadine and dexamethasone are dissolved in polyethylene glycol 400 and mixed with nipagin previously dissolved in a minimum amount of purified water from the rest of the volume; then ciprofloxacin dissolved in the minimum amount of water in the rest of the volume is added. Mix well and homogenize the emulsion. The pH of the emulsion is measured and, if necessary, adjusted with the citrate buffer solution with pH=7.8 (1 ml) until the optimal pH 4.5...5.0. The obtained emulsion is transferred into a 50 ml graduated glass and filled up to the required level with the rest of the solvent. The emulsion obtained has a homogeneous appearance, is free of suspended particles, and has a pleasant smell of volatile basil oil.
Amestecul se ambalează în recipiente din sticlă întunecată cu capacitatea de 50 g, se etanşează cu dop din masă plastică. The mixture is packed in dark glass containers with a capacity of 50 g, sealed with a plastic stopper.
Exemplu Example
Experimentele au fost efectuate pe 15 şoricei de laborator, masculi cu vârsta de 12 săptămâni şi greutatea corporală de 18…24 g la iniţierea studiului. Animalele de laborator au fost repartizate în 3 grupuri a câte 5 şoricei. La toate animalele până la iniţierea studiului s-a efectuat otoscopia pentru excluderea otitei. The experiments were performed on 15 laboratory mice, males aged 12 weeks and body weight of 18...24 g at the start of the study. The laboratory animals were divided into 3 groups of 5 mice each. Otoscopy was performed on all animals before the start of the study to rule out otitis.
Otita externă experimentală a fost provocată prin administrarea în conductul auditiv unilateral la fiecare animal de laborator a culturii Staphylococcus aureus 0,05 ml. Otita a fost diagnosticată prin otoscopie cu stabilirea următoarelor simptome: hiperemia tegumentelor urechii externe şi a conductului auditiv extern, culoarea roz a membranei timpanice, eliminări auriculare în conductul auditiv extern, înclinarea caracteristică a capului spre urechea afectată (în unele cazuri). Peste 3 zile după modelarea otitei acute a fost început tratamentul maladiei. Experimental otitis externa was induced by administering 0.05 ml of Staphylococcus aureus culture to each laboratory animal in the unilateral auditory canal. Otitis was diagnosed by otoscopy with the establishment of the following symptoms: hyperemia of the integuments of the external ear and the external auditory canal, pink color of the tympanic membrane, auricular discharges in the external auditory canal, the characteristic inclination of the head towards the affected ear (in some cases). More than 3 days after the modeling of acute otitis, the treatment of the disease was started.
La I grup s-a administrat preparatul studiat, la grupul II - separat concentraţii similare de ciprofloxacin, loratadin, dexametazon şi ulei de busuioc, la grupul 3 s-a administrat sol. Otinum. La toate grupele preparatele s-au administrat cu pipeta în urechea externă, câte 1 picătură de 2 ori pe zi. Zilnic s-a efectuat otoscopia pentru a stabili nivelul de afectare. La necesitate la animalele de laborator s-a efectuat toaleta conductului auditiv cu soluţie fiziologică. Vindecarea a fost determinată prin: lipsa eliminărilor în conductul auditiv extern, lipsa hiperemiei pielii din ureche, culoarea surie a membranei timpanice cu punctele de reper evidenţiate. La I grup vindecarea a fost constatată după 2…3 zile de administrare a preparatului studiat; la grupul II - după 4…5 zile de administrare; la grupul III - după 5…6 zile de administrare. Group I was administered the studied preparation, group II - separately similar concentrations of ciprofloxacin, loratadine, dexamethasone and basil oil, group 3 was administered salt. Otinum. In all groups, the preparations were administered with a pipette in the external ear, 1 drop twice a day. Daily otoscopy was performed to determine the level of damage. If necessary, laboratory animals were cleaned of the auditory canal with physiological solution. The healing was determined by: the lack of elimination in the external auditory canal, the lack of hyperemia of the skin in the ear, the tympanic membrane's brown color with highlighted landmarks. In the 1st group, healing was observed after 2...3 days of administration of the studied preparation; in group II - after 4...5 days of administration; in group III - after 5...6 days of administration.
În baza cercetării farmaceutice şi farmacologice a principiilor active ale ciprofloxacinei, loratadinului, dexametazonului şi uleiului de busuioc în combinaţie a fost elaborat un produs medicamentos nou cu acţiune polivalentă, manifestând următoarele proprietăţi: antiseptică, antiinflamatoare, regenerativă, antiexsudativă şi uşor anestezică, cu aplicare în clinică. Pentru prima oară se propune sub formă de picături auriculare combinaţia dintre un antibacterian fluorchinolon şi un remediu naturist în tratamentul afecţiunilor inflamatorii ale urechii. Based on the pharmaceutical and pharmacological research of the active principles of ciprofloxacin, loratadine, dexamethasone and basil oil in combination, a new medicinal product with polyvalent action was developed, showing the following properties: antiseptic, anti-inflammatory, regenerative, anti-exudative and slightly anesthetic, with application in clinic. For the first time, the combination of a fluoroquinolone antibacterial and a natural remedy in the treatment of inflammatory ear conditions is proposed in the form of ear drops.
Aşadar, a fost elaborat în laboratoarele catedrelor Universităţii un preparat medicamentos ce manifestă proprietăţi antiseptice, antiinflamatoare, regenerative. Therefore, a medicinal preparation with antiseptic, anti-inflammatory, regenerative properties was developed in the laboratories of the University departments.
1. Matcovschi C., Procopişin V., Parii B. Ghid farmacoterapeutic. Chişinău, 2006, p. 968 1. Matcovschi C., Procopisin V., Parii B. Pharmacotherapeutic guide. Chisinau, 2006, p. 968
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| MDA20130100A MD4291C1 (en) | 2013-12-27 | 2013-12-27 | Medicinal preparation for the treatment of otitis |
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| MDA20130100A MD4291C1 (en) | 2013-12-27 | 2013-12-27 | Medicinal preparation for the treatment of otitis |
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| MD4291B1 MD4291B1 (en) | 2014-07-31 |
| MD4291C1 true MD4291C1 (en) | 2015-02-28 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP3369422A4 (en) * | 2015-10-29 | 2018-12-05 | Teika Pharmaceutical Co., Ltd. | External preparation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP3369422A4 (en) * | 2015-10-29 | 2018-12-05 | Teika Pharmaceutical Co., Ltd. | External preparation |
Also Published As
| Publication number | Publication date |
|---|---|
| MD4291B1 (en) | 2014-07-31 |
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